NCT05073458

Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),

Detailed description

Prospective participants must have primary wAIHA as well as other protocol-defined criteria. After participants have been determined to be eligible for the study, they will be randomized to 2:1, with stratification factor of corticosteroid dose and hemoglobin (Hgb \<9 g/dL or ≥ 9 g/dL). Once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.

Conditions

• Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions

Type	Name	Description
DRUG	parsaclisinib	parsaclisib will be administered QD orally
DRUG	placebo	placebo will be administered QD orally follwed by Parsaclisinib in the open label period

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-10-17
• Completion: 2024-04-29
• First posted: 2021-10-11
• Last updated: 2025-11-03
• Results posted: 2025-01-15

Locations

56 sites across 13 countries: United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study